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Hervaxx Trials, page-2

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    "From I can find online gastric cancer treated with trastuzumab has a median survival of approximately 11 months. If the trial is to take 12 months to recruit 30 participants. Will it therefore take a further 12 months to show benefit from Hervaxx combinations?"From personal experience, I'd expect the trial doctors will know within a few months of a patient going onto the HER-Vaxx / Keytruda combination as to whether or not it will work. If it doesn't produce any improvements, then I'd expect the patients to die about 6-8 months after stopping treatment with trastuzumab. (It will be evident to the doctor's months before death that the tumours are spreading uncontrollably.) If the treatment keeps the disease stable or reduces the tumour load, then it will take longer. If you have a look at the study end points as listed in the study link you posted, you will see that overall survival from the combination is estimated to be an average of 12 months and therefore it will likely be at least 12 months after the last patient is dosed before the overall survival end point is met. All the other end points will occur before the overall survival end point.

    The Estimated Primary Completion Date of the study is 31 July 2023. These are the primary outcome measures:
    1. Frequency and Severity of Treatment-Emergent Adverse Events [safety and tolerability] of HER-Vaxx in combination with chemotherapy or pembrolizumab [ Time Frame: From date of enrollment through study completion, an average of 6 months ]Treatment-Emergent Adverse Events [safety and tolerability] will be graded according to CTCAE v5.0
    2. Objective Response Rate of HER-Vaxx in combination with chemotherapy or pembrolizumab [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, an average of 6 months] Objective Response Rate (ORR) measured from enrollment as the proportion of patients achieving a confirmed best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1

    Number 1 refers to the safety of the treatment and number 2 refers to whether or not is looks like the treatment works. As I stated earlier, if it doesn't work then the patients won't live much longer and is almost certainly why the timeframe is estimated to be 6 months. I expect we will have some news on the study in within 12 months from now, unless they have trouble recruiting patients.
 
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